Together Overcoming Diabetes - Great Plains

Culturally Grounded Diabetes Intervention With Lakota Populations in South Dakota

The goal of this research is to evaluate a scientifically rigorous diabetes intervention, Together Overcoming Diabetes (TOD), that has been tailored to address the unique underlying risk and protective factors and social determinants of diabetes among American Indian/Alaska Native (AI/AN) populations.

Study Overview

• Status: Recruiting
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: TOD Great Plains; Behavioral: Waitlist Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Courtney Claussen, PhD; Phone Number: 605-200-0043; Email: cclauss1@jh.edu

Study Locations

• United States
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Recruiting
      • Center for Indigenous Health - Great Plains Hub
      • Contact: Courtney Claussen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria - Adult Index Participants:

• 18 years and older
• Self-identifies as American Indian or Alaska Native
• Rapid City-based participants who reside within 1 hour transportation range of the Oyate Health Center
• Verification from a health provider to confirm Type 2 Diabetes diagnosis by laboratory test.
• Caregiver to a 10- to 25-year-old in their home at the time of screening.
• Willing to complete all implementation and follow-up assessments.
• Willing to be randomized for the intervention.

Exclusion Criteria - Adult Index Participants:

• Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
• Willing to serve as 'support person' for the adult participant.
• Has a circumstance that might impact successful participation based on provider judgment considering instances where diabetes control can become more difficult with advanced disease or special conditions including: pregnant, nursing, or planning to become pregnant, end-stage renal disease on dialysis, diabetes due to secondary causes such as Cushing's or Cystic Fibrosis, or any condition that may inhibit participation

Inclusion Criteria - Youth Support Participants:

• Between 10 years and 25 years old
• Self-identifies as American Indian or Alaska Native.
• Willing to serve as 'support person' for the adult participant.
• Willing to complete all implementation and follow-up assessments.
• Willing to be randomized for the intervention.

Exclusion Criteria - Youth Support Participants:

• Cognitively or visually impaired
• Youth in foster care (due to potential mobility of foster youth).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Waitlist Standard of Care; Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.	Behavioral: Waitlist Standard of Care; Participants who are waitlisted to receive the TOD intervention will receive Standard of Care.
Experimental: Together Overcoming Diabetes Intervention; Together Overcoming Diabetes curriculum adapted for Lakota caregivers and the caregivers families	Behavioral: TOD Great Plains; The adapted TOD intervention is rooted in the original TOD structure, delivery system, and home-visiting teaching schedule. Local enhancements include intervention topics and activities to address local adult caregivers' diabetes management and to promote families' modifiable risk and protective factors targeted by this proposal and informed by the Wicozani wellness concept and measurement. The TOD intervention includes targeted content taught approximately bi-weekly by family health coaches over a 16-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated hemoglobin (HbA1c)	Glycated hemoglobin as measured by a point-of-care A1c test	Baseline, 3 months, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); The NIH Community Engagement Alliance; Oyate Health Center
• Investigators: Principal Investigator: Donald Warne, MD, MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: IRB00029399; OT2HL158287 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No